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临床试验/NCT05420649
NCT05420649已完成不适用

Evaluation of the Feasibility and Safety of Laryngoscopic Microsurgery Under Non-intubation Anesthesia With Combination of Superior Laryngeal Nerve Block

Kaohsiung Veterans General Hospital.1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2020年10月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
49
试验地点
1
主要终点
PaCO2 after Laryngomicrosurgery

研究概览

简要总结

Nonintubated anesthesia applied in combination with high-flow nasal oxygen (HFNO) is an alternative strategy for laryngeal microsurgery (LMS). LMS is a common procedure in otolaryngology that typically requires endotracheal tube intubation under general anesthesia. Endotracheal tube intubation causes complications; a nonintubated strategy can avoid these complications and provide a clearer surgical field of vision, enabling vocal cord inspection and disposal. Administering a muscle relaxant can also help prevent bucking during surgery but can engender apnea and hypercapnia, which may have negative effects on hemodynamics. Therefore, the investigators assessed the effectiveness of a superior laryngeal nerve block (SLNB) with intravenous general anesthesia in maintaining spontaneous breathing and improving safety during LMS with nonintubated anesthesia.

详细描述

Laryngeal microsurgery (LMS) is among the most common operations in otolaryngology and typically requires general anesthesia administered through endotracheal tube intubation. Endotracheal tube intubation provides stable gas exchange, protects the airways by preventing secretions from falling into the lower respiratory tract, and enables the monitoring of parameters such as tidal volume and end-tidal CO2.

Nonintubated anesthesia applied in combination with transnasal humidified rapid-insufflation ventilatory exchange or high-flow nasal oxygen (HFNO) is another option for LMS. LMS with nonintubated anesthesia can avoid the complications caused by endotracheal tube intubation such as oral tissue trauma, tracheal trauma, and dental injury. Furthermore, LMS with nonintubated anesthesia can provide a clearer surgical field of vision that allows the vocal cords to be inspected and disposed of completely. Current practice in LMS with nonintubated anesthesia is to administer a muscle relaxant to help avoid bucking during the procedure. However, the administration of a muscle relaxant can lead to apnea and hypercapnia, which may negatively affect hemodynamics. Therefore, the investigators investigated the use of a superior laryngeal nerve block (SLNB) with intravenous general anesthesia to help the patient maintain spontaneous breathing and provide higher surgical safety during LMS with nonintubated anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •The patient who needed to undergo LMS.

排除标准

  • •Severe airway obstruction.
  • •Severe airway disease.
  • •American Society of anesthesiologists (ASA) physical state > III.
  • •Pregnancy or body mass index (BMI) ≥ 40 kg/m2.

研究组 & 干预措施

Intubated general anesthesia LMS

No Intervention

Patients received LMS with intubated general anesthesia

Non-intubated LMS with apnea

Experimental

Patients received non-intubated LMS with administration of muscle relaxant and optiflow(HFNO) device.

干预措施: Non-intubated Laryngomicrosurgery (Procedure)

Non-intubated LMS with spontaneous breathing

Experimental

Patients received non-intubated LMS optiflow(HFNO) device and maintained spontaneous breathing.

干预措施: Non-intubated Laryngomicrosurgery (Procedure)

结局指标

主要结局

PaCO2 after Laryngomicrosurgery

时间窗: ABG was measured immediately after the end of LMS

ABG was measured immediately after the end of LMS

次要结局

  • Heart rate (HR)(during the LMS procedure)
  • pH after Laryngomicrosurgery(ABG was measured immediately after the end of LMS)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuan-Yi Chia

Chief of Anesthesiology

Kaohsiung Veterans General Hospital.

研究点 (1)

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